NCT06979635

Assessing the Safety, Performance, and User Experience of the Tandem Mobi Automated Insulin Delivery System Among Young Competitive Athletes in Real-world Settings.

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Rabin Medical Center · Academic / Other
• Sex: All
• Age: 11 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

A single arm, interventional study with 12 weeks study phase preceded by a 2-week run in phase, aiming to evaluate the effectiveness and applicability of the Tandem Mobi automated insulin delivery system (Tandem Mobi Pump System) for competitive youth athletes with type 1 diabetes in real-world conditions.

Conditions

• Type 1 Diabetes

Interventions

Type	Name	Description
DEVICE	Tandem Mobi Hybrid Closed Loop (HCL) pump	Tandem Mobi Hybrid Closed Loop (HCL) pump with an integrated Control-IQ algorithm (CIQ), the Dexcom G7 continuous glucose monitoring sensor (CGM ) and Tandem Mobi Mobile App

Timeline

• Start date: 2025-06-01
• Primary completion: 2025-06-01
• Completion: 2025-06-01
• First posted: 2025-05-20
• Last updated: 2025-05-25

Locations

1 site across 1 country: Israel

Regulatory

• FDA-regulated device study